An interventional study of cholecalciferol in Vitamin D Deficiency, sponsored by Pontificia Universidad Catolica de Chile. Completed. Open to participants aged Up to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-13.
Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate vitamin D (VD) deficiency in the population of Chilean Antarctica and evaluate the efficacy and safety of VD supplementation to decrease VD deficiency and favorably influence biomarkers for bone, cardiovascular, and immune health risk in the inhabitants of Chilean Antarctica.
The present study consists of an initial cross-sectional evaluation of VD status and specific health biomarkers in inhabitants of Chilean Antarctica, followed by a randomized controlled trial evaluating two acceptable approaches of vitamin D supplementation (cholecalciferol 600 IU daily vs. 25000 IU weekly) in Antarctic inhabitants.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 75 is close to the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cholecalciferol 600 IU daily during one year or exit from Antarctica.
Dietary Supplement: cholecalciferol
Cholecalciferol 25000 IU once weekly during one year or exit from Antarctica.
Dietary Supplement: cholecalciferol
Administration of vitamin D3
Also known as: Vitamin D3
Change in serum 25-hydroxyvitamin D concentration
In Antarctic inhabitants not supplemented with VD that exit Antarctica before start of RCT phase of study.
Time frame: at end of Antarctic residency or 1 year (90-365 days), whichever came first
sun exposure
questionnaires
Time frame: at 0, 6, 12 months of Antarctic residency
sleep pattern
questionnaires
Time frame: at 0, 6, 12 months of Antarctic residency
food intake of VD
Food frequency questionnaire
Time frame: at 0, 6, 12 months of Antarctic residency
serum biomarkers for bone metabolism
intact PTH, calcium phosphorus, alkaline phosphatases, VD-binding protein
Time frame: at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first
serum high-sensitivity C-reactive protein (hsCRP)
Time frame: at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first
serum cathelicidin (LL-37) concentration
Time frame: at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile